Micro-Randomized Trial to Optimize Digital Oral Health Behavior Change Interventions

Dental Diseases Clinical Trial

— DCBI  

Official title:

Personalized Digital Behavior Change Interventions to Promote Oral Health

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05624489
• Other study ID #: IRB#21-001471
• Secondary ID: UG3DE028723
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2023
• Est. completion date: June 2024

Study information

• Verified date: October 2022
• Source: University of California, Los Angeles
• Contact: Vivek Shetty
• Phone: 3108255170
• Email: vshetty[@]g.ucla.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will involve a 10-week Micro-Randomized Trial (MRT) to inform the delivery of prompts (via mobile app push notifications) designed to facilitate adherence to an ideal tooth brushing protocol (2x2x4; 2 sessions daily, 2 minutes per session, all 4 quadrants).

Description:

The goal of the MRT is to investigate whether delivering (vs. not delivering) a prompt that contains engagement strategies grounded in decision science is beneficial in terms of promoting proximal oral health behavior (OHB) score, which reflects adherence to the 2x2x4 brushing protocol (Primary Aim) and also mobile health engagement (mHealth; Secondary Aim). Additionally, Exploratory Aims will concern (a) comparing different types of prompts in terms of proximal OHB score and mHealth engagement, (b) investigating the conditions in which prompts should be delivered to most effectively promote proximal OHB and mHealth engagement; and (c) investigating whether the effect of the engagement prompts (vs. no prompt) on OHB score varies across components of the 2x2x4 brushing regimen (i.e., frequency, duration, or coverage). Participants will receive an electronic toothbrush (eBrush) and a mobile app (Oralytics) that contains well-established behavior change strategies (e.g., goal setting, monitoring adherence, and feedback). Participants will be randomized twice per day - in the morning and the evening - to receive either (a) a push notification containing one of three (randomly selected) engagement strategies or (b) no notification. During the 10 weeks of the study, a Bayesian algorithm will iteratively adjust the probability of receiving a prompt or no prompt in any given randomization window, using prior behavioral data collected through the eBrush and mobile app. Data patterns suggesting positive effects of the prompts on adherence to brushing protocol, especially duration, will result in higher subsequent probabilities of receiving the prompts, whereas patterns suggesting null or negative effects will result in lower probabilities of receiving the prompts. Study results will inform the implementation of a smartphone-delivered behavior change intervention that further adapts the delivery of engagement prompts based on passively collected information from an eBrush and the mobile app.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults, age 18 or older.
• Fluent in English
• Dentulous/partially edentulous (18+ teeth; at least 2 teeth in each quadrant)
• Possess a smartphone (iOS or Android) with a data plan.
• Willing to allow the passive collection of data on tooth-brushing activities in the home setting for 10 weeks.

Exclusion Criteria:

• Not fluent in English
• Edentulous
• Unable to use a mobile device due to cognitive or physical impairments

Related Conditions & MeSH terms

• Dental Diseases
• Stomatognathic Diseases

Intervention

Behavioral:
• Engagement Strategies
The study's mobile app (Oralytics) will be used to deliver engagement prompts. The prompts contain messages that leverage three engagement strategies: reciprocity, reciprocity by proxy, and curiosity.

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proximal adherence to 2x2x4 OHB	Change in proximal OHB score between the current and next randomization	24 hours
Secondary	Proximal mHealth engagement	Engagement with Oralytics app (i.e., accessing the Oralytics app or clicking on the push notification) between the current and next randomization.	24 hours